Brief Inpatient Psychotherapy for Depression

NCT03091582 | Completed DMC

• 1 other identifier: Pro00046076
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the proposed pilot study is to seek to compare the efficacy of two brief psychological therapies during inpatient hospitalization - cognitive behavioral therapy (CBT) versus Behavioral Activation for Medical Inpatients with Depression (BAMID or BA) - for improving depressive symptoms, functioning, and quality of life (QOL). The treatments will consist of four sessions, which will be delivered during hospitalization.

Conditions

Depression

Keywords

Psychological Therapy

Outcome Measures

Primary Outcomes (1)

• Depressive Symptom Severity

  The PHQ-9 is used to measure depressive symptoms

  12 weeks

Secondary Outcomes (2)

• Functioning

  12 weeks

• Overall Health and Quality of life (QOL)

  12 weeks

Study Arms (2)

Cognitive behavioral therapy

EXPERIMENTAL

The Cognitive-Behavioral Therapy (CBT) intervention will focus on catastrophizing and rumination. CBT emphasizes the role of cognitive factors and behavioral factors on affective distress.

Behavioral: Cognitive factors; Behavioral: Behavioral factors

Behavioral Activation

EXPERIMENTAL

Behavioral Activation is grounded in learning theory and posits that lack of positive/active engagement of the person with his/her environment contributes to an increase in avoidant or passive behaviors and decreased reinforcement. An empirically validated treatment, behavioral activation reduces depressive symptoms and increase engagement of pleasant events.

Behavioral: Increase engagement of pleasant events

Interventions

Cognitive factors BEHAVIORAL

The Cognitive-Behavioral Therapy (CBT) intervention will focus on catastrophizing and rumination. CBT emphasizes the role of cognitive and behavioral factors on affective distress

Cognitive behavioral therapy

Behavioral factors BEHAVIORAL

The Cognitive-Behavioral Therapy (CBT) intervention will focus on catastrophizing and rumination. Behavioral factors on affective distress.

Cognitive behavioral therapy

Increase engagement of pleasant events BEHAVIORAL

Behavioral Activation is grounded in learning theory and posits that lack of positive/active engagement of the person with his/her environment contributes to an increase in avoidant or passive behaviors and decreased reinforcement. An empirically validated treatment, behavioral activation reduces depressive symptoms and increase engagement of pleasant events.

Behavioral Activation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Adults from 18-80; 2) PHQ\>12; 3) Medical conditions needing inpatient medical care.

You may not qualify if:

• \) Patients who unable to provide informed consent; 2) Patients deemed in critical medical condition; 3) Conditions that preclude administration of the PHQ for depression screening (e.g., delirium, dementia, acute stroke, loss of consciousness, substance intoxication or withdrawal, agitation, psychotic disorders); 4) Homeless patients, as patient follow-up by mail would be difficult; 5) Meeting criteria for involuntary admission due to imminent danger to self or others, as they are transferred to offsite psychiatric facilities.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Waguih W IsHak, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chairman for Education & Research Cedars-Sinai Medical Center

Model Details: After being clearly told that participation in the study will not impact subsequent care at CSMC, the patient agrees to participate, the patient will review and sign the informed consent form. Next, the patient will be randomized to either receive CBT or BA therapy, and scheduled for CBT or BA therapy sessions.

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 27, 2017
• Study Start: July 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: September 28, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)